ENZYMATIC CHOLESTEROL— 510(k) K810673

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K810673 for ENZYMATIC CHOLESTEROL, Substantially Equivalent on 1981-03-31. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 1981-03-12
Decision date: 1981-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.